NCT05381103 · Five Eleven Pharma, Inc.
PSMA-PET to Guide Prostatectomy
What this study is about
In this study, 196 patients will be randomly assigned 1:1 to either having only the the usual treatment MRI prior to surgery versus having the the usual treatment MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology.
View original scientific description
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Interventions
DIAGNOSTIC_TEST
PSMA-PET and SOC MRI
60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT
DIAGNOSTIC_TEST
SOC MRI
Standard of care MRI
Primary outcome measures
IIEF-EF sub scale score
Time frame: 1 month
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 3 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 6 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 12 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
IIEF-EF sub scale score
Time frame: 18 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR NCCN unfavorable intermediate risk OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND
- Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
- The patient desires to maintain erections following treatment
- Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant.
- Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Exclusion criteria
- Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
- Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
- Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Where
- Indianapolis, Indiana
Collaborators
Indiana University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 31, 2025 · Source of record for eligibility and locations